Uceris (budesonide) NDC 65649-651

NDC codes

FDA NDC Directory

Product NDC (as listed)65649-651Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65649-0651Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65649-651-03	65649065103	2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)Marketed from Dec 1, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Uceris
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — 2 mg/1
Dosage form: Aerosol, Foam
Route: Rectal
Labeler: Salix Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205613
Marketing start: Dec 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357cSPL ID 205783ee-5004-4fcb-a9d6-ce1ac824357cSPL set ID 230e4596-2a9b-4d55-b0a0-0cabbcff5289RxCUI 1596778, 1596779UNII Q3OKS62Q6X
Pharmacologic class: Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465649065103 followed by a unit qualifier and the quantity

Package 65649-0651-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 23, 2020.

Indications (excerpt from the label)

UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. UCERIS rectal foam is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 205613

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205613
Product	Strength	Form · route	Labeler	Product NDC
budesonide	Budesonide 2 mg/1	Aerosol, FoamRectal	Oceanside Pharmaceuticals	68682-658